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Public float (as of ): $74M (SEC filing) · Under $500M
PDUFA target date (company stated):
In December 2025, the FDA accepted our BLA for INO-3107 for review under the accelerated approval program as a potential treatment for adults with RRP and set the Prescription Drug User Fee Act (PDUFA) target date for October 30, 2026.
· “In December 2025, the FDA accepted for review the company’s BLA for INO-3107 under the accelerated approval program and set a target PDUFA date for October 30, 2026.” · SEC filing
· “In December 2025, the FDA accepted our BLA for INO-3107 for review under the accelerated approval program as a potential treatment for adults with RRP and set the Prescription Drug User Fee Act (PDUFA) target date for October 30, 2026.” · SEC filing
A Form 8-K is a report a company files with the SEC to announce a significant event between its regular reports.
10-Q
A Form 10-Q is a company’s quarterly report to the SEC, with unaudited financial statements.
10-K
A Form 10-K is a company’s annual report to the SEC, with audited financial statements.
Topline
Topline results are the main summary results of a clinical trial, released before the full data.
PDUFA
A PDUFA date is the target date by which the FDA aims to decide on a drug or biologic application.
NDA / BLA
A New Drug Application (NDA) or Biologics License Application (BLA) asks the FDA to approve a drug or biologic for sale.
1H / 2H
1H means January–June and 2H means July–December of the stated year, unless the company uses a different fiscal year.
Q1–Q4
Q1–Q4 (also written 1Q–4Q) are quarters of the year: Q1 is January–March, Q2 April–June, Q3 July–September and Q4 October–December, unless the company uses a different fiscal year.
NRXPNRX Pharmaceuticals · KETAFREE (preservative-free ketamine) · not stated in the cited filingGDUFA goal date (company stated)○ Quote matches the filingSEC ↗
11 days left
… the GDUFA goal date to November 10, 2026, citing that the reclassified amendment will not …Details⌄
NRX Pharmaceuticals, Inc. (NRXP) · KETAFREE (preservative-free ketamine) · not stated in the cited filing
Stage: Not stated
Public float: Unknown (no public float found in SEC filings)
GDUFA goal date (company stated):
The acknowledgement letter revised the GDUFA goal date to November 10, 2026, citing that the reclassified amendment will not require a substantial expenditure of FDA resources.
founder confirmed 2026-10-30 · AI quote review: machine_extracted_quote_verified
Earlier SEC statements (1)
· “The KETAFREE™ ANDA was refiled in September 2025, and the Company received a letter in November 2025 with a notice that FDA had received the file and assigning a summer 2026 decision date under the Generic Drug User Fee Act (GDUFA).” · SEC filing
ICCCImmuCell · Unaudited financial results for the quarter and nine months ended September 30, 2026Financial results○ Quote matches the filingSEC ↗
14 days left
… conference call on Friday, November 13, 2026, at 9:00 AM ET to discuss the unaudited financial …Details⌄
IMMUCELL CORP /DE/ (ICCC) · Unaudited financial results for the quarter and nine months ended September 30, 2026
Stage: Not stated
Public float (as of ): $50M (SEC filing) · Under $500M
Date the company stated:
The Company is planning to host a conference call on Friday, November 13, 2026, at 9:00 AM ET to discuss the unaudited financial results for the quarter and nine months ended September 30, 2026.
Public float (as of ): $67M (SEC filing) · Under $500M
Date the company stated:
On September 28, 2026, NeOnc Technologies Holdings, Inc. (the “Company”) issued a press release announcing that it is scheduled to meet with the U.S. Food and Drug Administration on November 17, 2026, for an in-person End-of-Phase 1 Type B meeting concerning NEO212.
founder confirmed 2026-10-30 · AI quote review: machine_extracted_quote_verified
Earlier SEC statements (1)
· “The target action date for the FDA decision is November 25, 2026.” · SEC filing
PYPDPolyPid · D-PLEX100 · Prevention of surgical site infections in patients undergoing abdominal colorectal surgeryPDUFA target date (company stated)○ Quote matches the filingSEC ↗
29 days left
… with a PDUFA goal date of November 28, 2026, including potential label expansion beyond …Details⌄
PolyPid Ltd. (PYPD) · D-PLEX100 · Prevention of surgical site infections in patients undergoing abdominal colorectal surgery
Public float: Unknown (no public float found in SEC filings)
PDUFA target date (company stated):
PolyPid’s management will also review the Company’s plans to maximize the value of D-PLEX₁₀₀, for which a New Drug Application (“NDA”) is under FDA Priority Review with a PDUFA goal date of November 28, 2026, including potential label expansion beyond colorectal surgery and potential geographic expansion.
founder confirmed 2026-10-30 · AI quote review: machine_extracted_quote_verified
Earlier SEC statements (1)
· “The Company anticipates a potential FDA decision in the first quarter of 2027 under the Prescription Drug User Fee Act (“PDUFA”) review timeline.” · SEC filing
COGTCogent Biosciences · bezuclastinib and sunitinib · GIST after prior imatinibPDUFA target date (company stated)○ Quote matches the filingSEC ↗
31 days left
PDUFA target action date of November 30, 2026Details⌄
Cogent Biosciences, Inc. (COGT) · bezuclastinib and sunitinib · GIST after prior imatinib
Public float: Unknown (no public float found in SEC filings)
PDUFA target date (company stated):
Relacorilant for patients with Cushing’s syndrome – New Drug Application for relacorilant resubmitted with a Prescription Drug User Fee Act (PDUFA) date of December 17, 2026
· “The FDA accepted the NDA submission and provided us with a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026 for lorundrostat.” · SEC filing
· “The FDA accepted the NDA submission and provided the Company with a Prescription Drug User Fee Act target date of December 22, 2026 for lorundrostat.” · SEC filing
· “Food and Drug Administration (FDA) accepted the NDA for lorundrostat for the treatment of hypertension in combination with other antihypertensive drugs and assigned a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026.” · SEC filing
· “The FDA accepted the NDA submission and provided us with a Prescription Drug User Fee Act (PDUFA) target action date of December 22, 2026.” · SEC filing
· “The FDA accepted the NDA submission and provided us with a PDUFA target action date of December 22, 2026.” · SEC filing
· “The FDA accepted the NDA submission and provided the Company with a Prescription Drug User Fee Act target action date of December 22, 2026.” · SEC filing
GILDGilead Sciences · anito-cel · relapsed or refractory multiple myeloma after at least three prior therapiesPDUFA target date (company stated)○ Quote matches the filingSEC ↗
54 days left
PDUFA target action date of December 23, 2026Details⌄
GILEAD SCIENCES, INC. (GILD) · anito-cel · relapsed or refractory multiple myeloma after at least three prior therapies
Public float (as of ): $496M (SEC filing) · Under $500M
PDUFA target date (company stated):
supplemental New Drug Application (sNDA) for IBTROZI with updated efficacy data in TKI-naïve and TKI-pretreated advanced ROS1+ NSCLC, with a target action date of January 4, 2027.